Director of Regulatory Affairs
BioCardia Inc.
PATRICK LEE is a regulatory affairs / QA professional with over 20 years of experience in FDA–regulated industries including health-care, medical device, and nutritional products. He currently serves as the Director of Regulatory Affairs at BioCardia, Inc (BCDA), where he is involved in regulatory, quality, and clinical activities worldwide in supporting BioCardia's product line. Prior to BioCardia, Patrick served in various regulatory affairs positions at Bay Area medical device companies. The product categories that he has worked in include neuro-implants, cardiovascular devices, laser devices, blood processing and stem cell harvesting devices, cell therapy biologics, and other combination products.
He received his BS in chemical engineering from Cornell, MS in engineering from Columbia, and MBA from the Anderson School at UCLA. He is a licensed professional engineer in the states of New Jersey and California and holds several patents. Mr. Lee holds the US Regulatory Affairs RAC (US) designation and is a certified quality auditor (CQA).
Saturday, September 21
9:00 AM – 5:00 PM
Sunday, September 22
8:00 AM – 4:00 PM